Medical device CE marking

MDCG 2024-10 Clinical evaluation of orphan medical devices published


The European Commission has published guidance on the clinical evaluation of orphan medical devices.

Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. Often, they are used to treat a rare disease or medical condition for which very few diagnostic or therapeutic options exist. Orphan devices can be crucial to fulfil an otherwise unmet medical need.

Today’s guidance provides criteria for determining when a medical device or an accessory for a medical device should be regarded as ‘orphan device’ under the Medical Devices Regulation 2017/745 (MDR). It aims to guide manufacturers and notified bodies when applying the MDR’s clinical evidence requirements and help overcome some of the challenges that lead to delays in patient access to orphan devices. The guidance includes the possibility for manufacturers and notified bodies to seek advice from European Medicines Agency expert panels on the orphan device status and the clinical data needed for their clinical evaluation.

The document can be downloaded in our library

Source: European Commission